NCT02308852

Brief Summary

Noninvasive brain stimulations (NIBS) will be used in healthy volunteers and in chronic stroke patients to improve bimanual activities and motor learning. Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying bimanual activities and motor learning in healthy volunteers and in chronic stroke patients. A neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) will be used for motor learning.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P75+ for not_applicable stroke

Timeline
56mo left

Started Oct 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Oct 2014Dec 2030

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

11.2 years

First QC Date

December 2, 2014

Last Update Submit

January 9, 2024

Conditions

StrokeDeficit in Manual Activities

Keywords

bi-manual , motor skill learning , stroke , chronic patients,neuro-rehabilitative robot

Outcome Measures

Primary Outcomes (1)

  • bimanual coordination

    The effect of intervention on bimanual motor coordination will be quantified before, during and after executive tasks.

    up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention

Secondary Outcomes (1)

  • standard unimanual evaluation

    immediately, 30, 60 min; and up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention)

Study Arms (2)

real tDCS

ACTIVE COMPARATOR

Patients will receive non-invasive and painless brain stimulation over the brain areas involved in cognitive aptitudes. tDCS will be applied during 20 minutes while patients will perform motor bimanual tasks

Device: tDCS

Sham tDCS

PLACEBO COMPARATOR

this will be exactly as for "real tDCS" unless that the tDCS will be rapidly turned off, unbeknown from patients-therapist-examinator (double-blind trial)

Device: tDCS

Interventions

tDCSDEVICE
Sham tDCSreal tDCS

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stroke with at least slight deficit

You may not qualify if:

  • epilepsy
  • contraindication to tDCS and/or to fMRI
  • presence of metal in the head
  • inability to understand / complete behavioral tasks
  • chronic intake of alcohol or recreational drugs
  • major health condition
  • presence of pacemaker (for the fMRI part only)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital CHU Dinant Godinne UcL Namur

Yvoir, 5530, Belgium

Location

Related Publications (2)

  • De Laet C, Herman B, Riga A, Bihin B, Regnier M, Leeuwerck M, Raymackers JM, Vandermeeren Y. Bimanual motor skill learning after stroke: Combining robotics and anodal tDCS over the undamaged hemisphere: An exploratory study. Front Neurol. 2022 Aug 18;13:882225. doi: 10.3389/fneur.2022.882225. eCollection 2022.

    PMID: 36061986DERIVED

  • Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

    PMID: 33175411DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: tDCS real versus sham tDCS (this is what this is)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professer Yves Vandermeeren

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 4, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations

BE(1)